RDPAC行业行为准则 2022年修订版

目录TableofContents1.1范围11第二条医学互动交流活动的基本原则2.1医学互动交流活动的基本原则14第三条药品获得上市许可之前的信息交流及在药品标明的适用范围之4.1药品信息的一致性4.2准确和不误导4.3实证20第六条电子版推广材料，包括音像Article3Pre-ApprovalCommun21第七条与医疗卫生专业人士的医学7.1医学互动交流项目7.1.1涉及出国的医学互动交流项目7.1.2医学互动交流项目中的药品推7.1.3适当的地点/住宿7.1.4限制7.1.5娱乐7.2支持7.2.1直接支持个人医疗卫生专业人士7.3服务费7.4讲者项目7.4.1讲者项目的目的7.4.2选择医疗卫生专业人士讲者7.4.3对参会者的要求7.5演示材料的审阅7.6礼品及其他7.6.1禁止提供礼品7.6.2推广辅助用品7.6.3为提高医疗及病患服务的医用7.6.4为提高病患服务的信息及教育7.1.1MedicalInteractionProgramsInvolvingForeignTravel7.1.2PromotionalInformationatMedicalInteractionPrograms7.1.3AppropriateVenue/Accommodation7.1.4Limits7.1.5Entertainment7.2.1DirectSupporttoIndividualHealthcareProfessionals7.4.1PurposeofSpeakerPrograms7.4.2SelectionofHealthcareProfessionalSpeakers7.4.3RequirementsonAttendees7.6.1ProhibitionofGifts7.6.2PromotionalAids7.6.3ItemsofMedicalUtilitytoEnhancetheProvisionofMedicalServicesandPatientCare7.6.4Informational&EducationalItemsthatEnhancePatientCare8.1样品8.2有效控制和责任落实9.1透明度10.1资助10.2赞助10.2.1独家赞助10.3对医疗卫生组织的尽职调查10.4专家咨询会议11.1范围11.2参与声明11.3书面文件11.4活动13.1程序13.2培训13.3药品推广材料的审批8.2ControlandAccouArticle12Supportfor56第十四条对准则的违反，投诉与准Articl则的执行动的指南说明77附件三投诉和争议解决规程RDPACCodeofPracticeI0102IRDPAC行业行为准则值观和原则的文化――最重要的是，商业行为以及IFPMA成员与医疗行这些核心理念为IFPMA行为准R&D-basedbiopharmaceuticalmembercompaniesoftheInternationalFederationofPharmaceuticalManufacturersandAssociations(IFPMA)areresponsibleforthediscoveryofmostnewmedicinesandvaccines,whichtheygoontodevelop,promote,sellanddistributeinanethicalmannerandinaccordancewithalltherulesandregulationsformedicinesandhealthcare.Indoingso,theyprovidethehealthcarecommunitywiththelatestscientificandeducationalinformationtoimproveunderstandingoftreatmentoptionsavailabletopatientsandsupporthigh-qualitypatientcare.IFPMAhastakenanewapproachandmovedfromaCodebasedonrulestoaculturegroundedinintegrity,valuesandprinciples–and,mostimportantly,patienttrust.TheEthosisthefoundationthatshapeshowtheR&Dbasedbiopharmaceuticalindustrysustainstrustbasedonthecorevaluesofcare,fairness,respectandhonestyinlinewithever-changingsociety'sexpectations.TheEthosservestoinstillacultureofethicsandintegrityneededtoguideourbusinessbehavioursandinteractionsbetweenIFPMAmembersandthehealthcarecommunity.TheEthosunderpinstherulesoftheIFPMACodeofPracticeandprovidesaframeworktobehavewithintegritynomatterhowtestingthecircumstances.保护那些使用我们产品的人的安个产品生命周期。通过创新的产品和服务改善全球健和可靠的安全性的产品。量质新创心量质新创心信诚任责任信诚任责任支持和尊重公平贸易惯例和公开竞表我们行事的外部第三方的恰当监诚实和病患服务的进步。畅所欲言诚透明畅所欲言诚透明医疗服务提立教育隐私教育隐私Protectthesafetyofthosewhouseourproducts–fromtheconductofclinicaltrialsandthroughouttheproductlifecycle.InnovationImproveglobalhealththroughinnovativeproductsandservices,upholdingthehighestethical,scientific,andmedicalstandards.QualityCommittoprovidinghigh-qualityproductsthathaveprovenclinicalefficacyandhaveareliablesafetyprofile.ytilauQnoitavonnIrCTrActwithinytilauQnoitavonnIrCTrActwithinhonestytoim careandbunIse“rtytirFgetytilibatnuoccAusttegrityandnIse“rtytirFgetytilibatnuoccAusttegrityandprovepatientildtrustwithSupportandrespectfairtradepracticesandopencompetition.IntegrityActresponsibly,ethically,andprofession-ally.Donotoffer,promise,provide,oracceptanythingofvalueinordertoinappropriatelyinfluenceadecision,gainanunfairadvantage.AccountabilityBeaccountableforouractionsanddecisions,includingtheappropriateoversightofexternalthirdpartiesthatactonourbehalf.Supportandrespectfairtradepracticesandopencompetition.SpeakingUpActresponsibly,ethically,andprofes-sionally.Donotoffer,promise,provide,oracceptanythingofvalueinordertoinappropriatelyinfluenceadecision,gainanunfairadvantage.TransparencyBeaccountableforouractionsanddecisions,includingtheappropriateoversightofexternalthirdpartiesthatactonourbehalf.SpeakingUpncyHσ“eTsransparethoseweSpeakingUpncyHσ“eTsransparethosewesrespecttheiofhealthcar patients,stakehRe〉μectEducationPrivacyerveRe〉μectEducationPrivacyerveandtondependenceeproviders,andotherolders.Respectallpeopleandembraceacultureofdiversityandinclusion.Protecttheenvironment.Treatanimalsunderourcareresponsibly.PrivacyRespectprivacyrightsandappropriatelymanageandprotectpersonalinforma-tion.EducationSupporttheadvancementofthescientificandmedicaleducationfortheultimatebenefitsofpatients.RDPACCodeofPracticeI05RDPACCodeofPractice06IRDPAC行业行为准则1.RDPAC准则适用于RDPAC会员公司。非RDPAC会员的制药公司不在RDPAC准则的规治范围之内。RDPAC鼓励非会员公司和其他需要向医疗卫生专业人士推广药品或服务、或需要与医疗卫生专业人士、医疗卫生组织、患者组织和患者开展互动交流活动的组织都能遵守与RDPAC准则所规定药品推广及相关互动交流道德标准相类似有会员公司的雇员，以及代表会员公司执2.RDPAC准则不适用于下列活动：TheRDPACCodeofPractice(hereinafteralsothe"RDPACCode")coversmedicalinteractionswithhealthcareprofessionals,healthcareorganizations,patientorganizationsandpatients,andthepromotionofpharmaceuticalproducts.Annotation1-5:1.TheRDPACCodeappliestoRDPAC'smembercompanies.PharmaceuticalcompaniesthatarenotmembersofRDPACfalloutsidethereachoftheRDPACCode.RDPACencouragessuchcompanies–andotherorganizationsmarketinghealthcareproductsorservicestohealthcareprofessionals,orthosehavinginteractionswithhealthcareprofessionals,healthcareorganizations,patientorganizationsandpatients-tofollowethicalstandardsforpromotionandinteractions,similartothosesetforthintheRDPACCode.ItshouldbenotedthoughthatallrelevantmembercompanyemployeesarecoveredbytheCode,aswellassubcontractorsthatcarryouttasksonbehalfofthemembercompany,suchasconsultants,contractedsalesrepresentativesorPRagents.2.ThisCodespecificallydoesnotseektoregulatethefollowingactivities:•直接针对一般公众所进行的处方药推广•直接针对消费者就自我诊疗药品进行的非处方药（OTC）推广；•Promotionofprescriptiononlypharmaceuticalproductsdirectlytothegeneralpublic(i.e.directtoconsumeradvertising);•Promotionofself-medicationproductsthatareprovided"overthe-counter"(OTC)directlytoconsumerswithoutprescription;RDPACCodeofPracticeI07包括：向商业性组织进行的药品推广和3.不适用RDPAC准则的非推广类信息可包括为回答针对某个药品的具体问题而进行的往来函件及其附随的非推广类信息资料。有关会员公司的非推广类的一般信息（如面向公司投资者及现有的或未来的员工提供的信息），包括财务数据、公司研发项目介绍、及有关影响会员公司及其产品的药事管理最新进展的讨论等，也不适用RDPAC准则。4.RDPAC准则适用于向医疗卫生专业人士进行的非处方药的推广，而不适用于向消费5.RDPAC准则适用于向既是有业务关系的商业性组织同时也是医疗卫生专业人士的主体进行的药品推广和营销，比如药剂师自有的药店。在与此类主体的往来中，会员公司应尊重和重视其作为医疗卫生专业人•Pricingorothertradetermsforthesupplyofpharmaceuticalproducts,includingpromotionandmarketingofpharmaceuticalproductstocommercialcustomers;•Certaintypesofnon-promotionalinformationoractivities;and•Promotionofmedicaldevices.3.Examplesofnon-promotionalinformationthatarenotcoveredbytheCodeincludecorrespondence,possiblyaccompaniedbymaterialofanon-promotionalnature,neededtoansweraspecificquestionaboutaparticularmedicinalproductisnotcoveredbytheCode.Non-promotional,generalinformationaboutmembercompanies(suchasinformationdirectedtoinvestorsortocurrent/prospectiveemployees),includingfinancialdata,descriptionsofresearchanddevelopmentprogram,anddiscussionofregulatorydevelopmentsaffectingthemembercompanyanditsproductsisalsonotcoveredbytheCode.4.TheRDPACCodeappliestothepromotionofover-the-counter(OTC)productsdirectedtowardshealthcareprofessionals.However,thepromotionofOTCproductstoconsumersfallsoutsidethescopeofthisCode.5.TheRDPACCodeappliestothepromotionandmarketingofpharmaceuticalproductstocommercialcustomerswhoarealsopracticinghealthcareprofessionals,suchasapharmacistwhooperateshis/herownpractice.Inanydealingswithsuchacustomer,membercompaniesshouldrespectthecustomer'sroleasahealthcareprofessionaland,ifapplicable,complywiththerequirementsoftheRDPACCode.RDPACencouragescompetitionamongmembercompanies,andtheRDPACCodedoesnotrestrainorregulatecommercialtradetermsforthesupplyofpharmaceuticalproducts,tocustomers.08IRDPAC行业行为准则治疗、诊断人的疾病，有目的地调节人的生理机能并规定有适应症或者功能主治、用法和用量的物质，•“推广”指由某会员公司通过各种方式――包括互联网，以促进其药品的处方、推荐、供应、用于病人或为病人自用等为目的的，针对医疗卫生专业人士所进行的或组织、或其他任何在其专业活动中可能开具药品处方或推荐、采购、供应药域从事任何专业活动的组织，包括ForthepurposesoftheRDPACCode:•"pharmaceuticalproduct"means,assetforthinArticle2oftheDrugAdministrationLaw,anyarticlesintendedforuseintheprevention,treatmentordiagnosisofhumandiseases,orintendedtoeffectthepurposiveregulationofhumanphysiologicalfunctions,forwhichindicationsormajorfunctions,usageanddosageareprescribed.TheyincludetraditionalChinesemedicines,chemicaldrugs,biologicproducts,etc.•"promotion"meansanyactivityundertaken,organizedorsponsoredbyamembercompanywhichisdirectedathealthcareprofessionalstopromotetheprescription,recommendation,supply,administrationorconsumptionofitspharmaceuticalproduct(s)throughallmethodsofcommunications,includingtheinternet.•"healthcareprofessional"meansanymemberofthemedical,dental,pharmacyornursingprofessionsoranyotherpersonwhointhecourseofhisorherprofessionalactivitiesmayprescribe,recommend,purchase,supply,oradministerapharmaceuticalproduct.•"healthcareorganization"meansanorganizationthatperformsanyprofessionalactivitiesinthehealthcarearea,includingwithoutlimitation:(i)medicalinstitutions;(ii)medicalassociations,physiciansocieties,andhospitalassociations;(iii)industryassociations;and(iv)charitablefoundations.RDPACCodeofPracticeI09士组成的机构，或提供医疗服务、和/或进行医疗研究的机构，例如专业学会及协会或医疗卫生专业人士提供、从其获得或与之交流医学立或组建、在中国境内有实质性投公司的研发类制药企业，包括外商投资企业或其他由前述中国境外研发类制药企业在中国依法设立的机们的家人和/或护理人员的利益和由医疗卫生专业人士就药品或医疗器械产品或任何医学或科学知识向医疗卫生专业人士参会者发表演讲•"medicalinstitution"meanstypicallyanorganizationthatiscomprisedofhealthcareprofessionalsand/orthatprovideshealthcareorconductshealthcareresearch,e.g.,publichospitals,privatehospitals,andInternethospitals.•"medicalinteraction"or"medicalinteractionprograms"meanseventsthroughwhichmembercompaniesprovide,receiveorexchangemedicaland/orscientificinformationto,fromorwithmedicalinstitutions,academicassociationsorhealthcareprofessionals.•"membercompany"meansanyR&D-basedpharmaceuticalcompanylawfullyestablishedorincorporatedoutsideofChinawithsubstantialinvestmentoroperationalinterestsinChinathatbecameamemberofRDPAC,includingaforeign-investedenterpriseorotherlegalentityregisteredinChinabysuchanoverseasR&D-basedpharmaceuticalcompany.•"patientorganization"meansanot-for-profitinstitutionthatprimarilyrepresentstheinterestsandneedsofpatients,theirfamiliesand/orcaregivers.•"speakerprogram"meansaprogramorganizedbyamembercompanyatwhichahealthcareprofessionalmakesaspeechorpresentationtohealthcareprofessionalattendeesaboutadrugormedicaldeviceproductoranymedicalorscientificknowledge.1010IRDPAC行业行为准则RDPACCodeofPracticeI112.1医学互动交流项目的基本其他利益相关人士开展医学互动交流项目的目的是造福患者和提高医疗水平。医学互动交流项目的重点应集中在向医疗卫生专业人士传达药品信息、提供科学及教育方面的2.2医学互动交流项目的透明度通过适当地公开与医疗机构、相关专业学会及协会、以及医疗卫生专业人士的医学互动交流项目，逐步提高医学互动交流项目的透明度，提升监管机构以及公众对会员公司及其使用相关的材料，无论其性质是否属于推广，均应明示该材料系Article2Medicalinteractionprogramsthatmembercompaniesconductinrelationtohealthcareprofessionalsandotherstakeholdersareintendedtobenefitpatientsandtoenhancethepracticeofmedicine.Medicalinteractionprogramsshouldbefocusedoninforminghealthcareprofessionalsaboutmedicines,providingscientificandeducationalinformationandsupportingmedicalresearchandeducation.Membercompaniesarecommittedtoimprovingthetransparencyofmedicalinteractionprogramsinrelationtomedicalinstitutions,relevantacademicassociationsandhealthcareprofessionalsthroughappropriatedisclosureoftheseprogramsonalegitimatebasis,soastoearnmoretrustfromregulatorybodiesandthegeneralpublicwithregardtomembercompaniesandtheindustryasawhole.Materialrelatingtopharmaceuticalproductsandtheiruses,whetherpromotionalinnatureornot,whichissponsoredbyamembercompany,shouldclearlyindicatebywhomithasbeensponsored.12IRDPAC行业行为准则学互动交流项目，无论其性质是否属于推广，均应在合法前提下通过日程、条幅、海报或其他方式明示由某会员公司组织或赞助。会员公司不得对其学术活动作任何形式的隐藏或掩饰。如果会员公司赞助第三方组织的医学互动交流项目，则需在主办方知情并同意的情况下做备案系统，通过合理清晰的分类，准确地记录有关医学互动交流项目涉及的费用、提供给医疗卫生专业人士的相关利益等。费用类别可包括但不限于捐赠、资助、赞助、会议费、讲课费、咨询费等。明确区分与医疗卫生组织及医疗卫生专业人士互动产生的费用和内部员工费疗卫生专业人士的知情同意为前提。尤其针对电子邮件推送、社交媒体等线上互动活动，应确保获得相关的知情同意并授权后，再开展相关Medicalinteractionprogramshostedorsponsoredbymembercompanies,whetherpromotionalinnatureornot,shouldclearlyindicatebywhomithasbeenhostedorsponsored,throughagenda,banner,posterorothereffectivemeasures,underthepremisethatsuchdisclosurewillnotbreachlawsandregulations.Academicactivitiesshouldnotinanywaybeconcealedordisguisedbymembercompanies.Ifamembercompanysponsorsmedicalinteractionprogramsorganizedbyathirdparty,theabovedisclosureshouldbemadesubjecttotheknowledgeandconsentoftheorganizer.Membercompaniesshouldhaveacomprehensiveinternalrecordingandfilingmechanismtoaccuratelydocument,withreasonableandclearclassifications,expendituresandbenefitsprovidedtohealthcareprofessionalsthatareassociatedwithmedicalinteractionprograms.Theclassificationsofexpendituresmayinclude,withoutlimitation,donation,grant,sponsorship,meetingexpenses,speakerfees,consultancyfees,etc.Thereshouldbeclearseparationbetweenexpendituresassociatedwithinteractionwithhealthcareorganizationsandhealthcareprofessionalsandthoseforinternalexpensesforemployees.Medicalinteractionprogramsshouldbepremisedontheinformedconsentofhealthcareprofessionals.Inparticular,foronlineinteractionsthroughpushemail,socialmedia,etc.,theinformedconsentandappropriateauthorizationshouldbeobtainedpriortothecommencementofrelevantactivities.RDPACCodeofPracticeI136.当会员公司以资助或其他方式安排将其推广材料刊登在有相关资质的纸质或电子媒体上，这些推广材料不得有使人误解其为Annotation6:6.Whereamembercompanyfinancesorotherwisesecuresorarrangesthepublicationofpromotionalmaterialinqualifiedpaperorelectronicmedia,suchpromotionalmaterialmustnotresembleindependenteditorialmatter.14IRDPAC行业行为准则许可之前，不得从事为在中国上市对科学和医学发展动态的充分知情权。它既不限制对药品的科学信息作充分适当的沟通，包括通过专业的科学或大众媒体以及在专业的科学交流会议上公布有关药品的科研准则或规章的要求或号召向利益相Article3NopharmaceuticalproductshouldbepromotedforuseinChinauntiltherequisiteapprovalformarketing(manufacturingorimporting)forsuchusehasbeengivenbytheNMPA.Thisprovisionisnotintendedtopreventtherightofthescientificcommunityandthepublictobefullyinformedconcerningscientificandmedicalprogress.Itisnotintendedtorestrictafullandproperexchangeofscientificinformationconcerningapharmaceuticalproduct,includingappropriatedisseminationofinvestigationalfindingsinscientificorlaycommunicationsmediaandatscientificconferences.Norshoulditrestrictpublicdisclosureofinformationtostockholdersandothersconcerninganypharmaceuticalproduct,asmayberequiredordesirableunderanyapplicablelaws,regulations,codes,orrules.RDPACCodeofPracticeI15注释7：7.会员公司在药品获得上市许可前，或就药品说明书之外的信息与医疗卫生专业人士均应由会员公司医学专业人员进行或在医对药品获得上市许可之前信息交流的禁止并不妨碍在遵守各项法律法规和行政规章的前提下开展的药品慈善使用项目。会员公司应努力确保有关药品慈善使用项目的信息交流活动不演变为某个未获得上市许Annotation7:7.Pre-approvaloroff-labelcommunicationwithhealthcareprofessionals,whetherinverbalorwrittenform,shouldbeconductedbyorunderthesupervisionofmedicalexpertsofthemembercompanies.Theprohibitionofpre-approvalcommunicationdoesnotpreventcompassionateuseprogramswhichmustofcoursecomplywithallapplicablelaws,regulationsandadministrativerules.Careshouldbetakentoensurethatcommunicationsforacompassionateuseprogramarenot,ineffect,promotionsforanunlicensedmedicineoruse.部门批准的药品信息相一致。在遵守药品信息推广应与中国药品主管部门批准的药品信息相一致的要求同时，中国的医疗卫生专业人士应及时获得在世界其他国家传播的药8.会员公司应根据中国药品行政法律法规的要求或在其他适当的情况下提供与其在其他国家所提供的信息相同的主要产品信息（如：药品使用禁忌及警示、预防措施、Article4PromotionshouldnotbeinconsistentwithpharmaceuticalproductinformationapprovedbytheNMPA.RespectingtherequirementthatpromotionshouldbeconsistentwiththelabelandapprovedusesbytheNMPA,Chinesehealthcareprofessionalsshouldhaveaccesstosimilardatatothosebeingauthorizedforcommunicationinothercountriesoftheworld.Annotation8:8.WherenecessaryorappropriatewithinthecontextofChineseregulatoryrequirements,membercompaniesshouldprovidethesamecoreproductinformation(suchascontraindications,warnings,precautions,sideeffectsanddosage)asitprovidesinothercountries.16IRDPAC行业行为准则Promotionalinformationshouldbeclear,legible,accurate,balanced,fair,andsufficientlycompletetoenabletherecipienttoformhisorherownopinionofthetherapeuticvalueofthepharmaceuticalproductconcerned.Promotionalinformationshouldbebasedonanup-to-dateevaluationofallrelevantevidenceandreflectthatevidenceclearly.Itshouldnotmisleadbydistortion,exaggeration,undueemphasis,omissionorinanyotherway.Everyeffortshouldbemadetoavoidambiguity.Absoluteorall-embracingclaimsshouldbeusedwithcautionandonlywithadequatequalificationandsubstantiation.Descriptionssuchas'safe'and'nosideeffects'shouldgenerallybeavoidedandshouldalwaysbeadequatelyqualified.9.对医学和科学文献或对个人交流文件的摘录应忠实于原文（法规和规章要求对原文进行改编和修订的除外，在此情况下应清楚显示所作的改编和修订），并准确地注明出处。对文献的摘录不应曲解作者的真Annotation9:9.Quotationsfrommedicalandscientificliteratureorfrompersonalcommunicationsshouldbefaithfullyreproduced(exceptwhereadaptationormodificationisrequiredinordertocomplywithanyapplicableregulationsoradministrativerules,inwhichcaseitmustbeclearlystatedthatthequotationhasbeenadaptedand/ormodified)andtheprecisesourcesidentified.Quotationsshouldnotchangeordistorttheintendedmeaningoftheauthororthesignificanceoftheunderlyingworkorstudy.RDPACCodeofPracticeI1710.对两种不同药品的比较式表述仅可针对有对应性和可比性的内容进行，且应加以充分的实证。在可以进行比较式表述的情况Promotionshouldbecapableofsubstantiationeitherbyreferencetotheapprovedlabelingorbyscientificevidence.Suchevidenceshouldbemadeavailableonrequesttohealthcareprofessionals.Membercompaniesshoulddealobjectivelywithrequestsforinformationmadeingoodfaithandshouldprovidedatawhichareappropriatetothesourceoftheinquiry.Annotation10:10.Anycomparisonmadebetweendifferentpharmaceuticalproductsshouldbebasedonrelevantandcomparableaspectsoftheproductsandbecapableofsubstantiation.Comparativeclaims,wherepossible,shouldnotbemisleading.18IRDPAC行业行为准则(a)药品名称（通常为药品的商品(b)药物活性成份（应尽可能地使用(c)制药公司或药品代理公司的名称(e)处方信息概要，包括已经批准的一项或多项适应症、用法用量，以及对禁忌症提示和副作用的简Article5SubjecttoadditionalrequirementsundertheChineselawsandregulations,allprintedpromotionalmaterialsmustbelegibleandinclude:(a)thenameoftheproduct(normallythebrandname);(b)theactiveingredients,usingapprovednameswheretheyexist;(c)thenameandaddressofthepharmaceuticalcompanyoritsagentresponsibleformarketingtheproduct;(d)dateofproductionofthematerial;(e)"abbreviatedprescribinginformation"whichshouldincludeanapprovedindicationorindicationsforusetogetherwiththedosageandmethodofuse;andasuccinctstatementofthecontraindicationsprecautionsandsideeffects.RDPACCodeofPracticeI19注释11：11.科学或医学文章的翻印本在单独使用时不构成“药品推广材料”，因其非由制药公司制作；但如果将它们连同由制药公司制作的其他文件一起发送到医疗卫生专业人士手中，则这些翻印本就转变为药品推广材料。一旦某个推广材料中提及或者包含了科学或医学的论文或研究报告，或这些论文报告与推广材料一起被发送给相对人时，推广人均应对论文或报告的出处作清并被包含在推广材料中，或与推广材料一起被发送给相对人的非文字信息（包括图表、示图、照片或者表格等）的翻印，推广人均须清楚地注明出处，且翻印应忠实Annotation11:11.Reprintsofscientificandmedicalarticles,whenusedasstandalonedocuments,arenotdevelopedbypharmaceuticalcompaniesandassuchcannotbeconsideredaspromotionalmaterials.If,however,theyareproactivelypresentedtoahealthcareprofessionaltogether,withother,company-originateddocuments,theythenbecomepromotionalmaterials.Inallcases,wherepromotionrefersto,includes,orispresentedtogetherwithscientificormedicalarticlesorstudies,clearreferencesshouldbeprovided.Anyreprintofartwork(includinggraphs,illustrations,photographsortables)takenfromarticlesorstudiesandincludedorpresentedwithpromotionalmaterialsshouldclearlyindicatethesourceoftheartworkandbefaithfullyreproduced.20IRDPAC行业行为准则(a)制药公司的名称以及推广所针对(b)推广内容应适合于其所针对的受(c)其制作（内容、链接等）对其所(d)针对中国市场的信息应符合中国Article6Thesamerequirementsshouldapplytoelectronicpromotionalmaterialsasapplytoprintedmaterials.Specifically,inthecaseofpharmaceuticalproductrelatedwebsites:(a)theidentityofthepharmaceuticalcompanyandoftheintendedaudienceshouldbereadilyapparent;(b)thecontentshouldbeappropriatefortheintendedaudience;(c)thepresentation(content,links,etc.)shouldbeappropriateandapparenttotheintendedaudience;and(d)informationspecifictoChinashouldcomplywithalltheChineselawsandregulations.RDPACCodeofPracticeI21生专业人士赴其本国以外参加医学互动交流项目（包括支持个人参加除非满足IFPMA行为准则（2019）以及IFPMA关于赞助互动交流活动的指南说明（以下称“IFPMA赞助12.会员公司只可在理由充分的情况下组织医疗卫生专业人士赴其本国以外参加医学互(a)有关活动所邀请的大部分医疗卫生专业人士都来自其本国以外，且出于会议行程及安全的考虑，在境外举办该活动更Article77.1.1MedicalInteractionProgramsInvolvingNomembercompanymayorganizeorsponsoramedicalinteractionprogramforhealthcareprofessionals(includingsupportingindividualstoattendsuchamedicalinteractionprogramasdescribedinArticle7.2)thattakesplaceoutsideoftheirhomecountryunlesstheprinciplesandrequirementssetbytheIFPMACodeofPractice2019,aswellastheIFPMANoteforGuidanceonSponsorshipofEventsandMeetings(hereinafter"IFPMAGuidanceonSponsorship")aresatisfied.Annotation12:12.Amembercompanycanonlyorganizemedicalinteractionprogramsinvolvingforeigntravelifitisjustified,i.e.:(a)Asignificantproportionoftheinvitedhealthcareprofessionalsarefromoutsideoftheirhomecountry,anditmakesgreaterlogisticalorsecuritysensetoholdtheeventinsuchothercountry;or22IRDPAC行业行为准则(b)作为有关活动主题的相关资源或专家均RDPAC准则所指的“本国”是指相关此外，会员公司在评价医学互动交流项目地点或场所的适当性时，或者在决定是否赞助医学会等第三方组织的医学互动交流项目时，或者在审查会议官方宣传材料和网站时，应按照IFPMA赞助指南所提供的标准进行评价。该指南的具体内容请见本准则附件一，或参考在IFPMA官网发布/更新的该指南文件（https://www./resources/publications/）。7.1.2医学互动交流项目中的药品推座谈会上通过展台或直接分发给参会者的方式推广某个/些尚未在会议所在国获得上市许可、或虽获得上市许可但许可的内容和条件与其他国家有所不同的药品，但还须同时•会议所在国法律允许进行此种推•会议本身应当是真正意义上的国应来自会议所在国以外的其他国(b)Therelevantresourceorexpertisethatistheobjectorsubjectmatteroftheeventislocatedoutsideofthehealthcareprofessional'shomecountry.UndertheRDPACCode,thehomecountryofahealthcareprofessionalisthecountryinwhichhe/shepractices.Also,membercompaniesshouldrefertotheCriteriasetbytheIFPMAGuidanceonSponsorshipwhenassessingtheappropriatenessoftheLocationofamedicalinteractionprogram,ortheVenueofamedicalinteractionprogram,orwhendecidingwhethertosupportamedicalinteractionprogramorganizedbyathirdpartysuchasamedicalsociety,orwhenreviewingtheOfficialmeetingmaterialsandwebsitesofamedicalinteractionprogram.FordetailsseeIFPMAGuidanceonSponsorshipinAppendixIofthisCode,orrefertotheGuidancepostedandupdatedonIFPMAWebsite（/resources/publications/）.7.1.2PromotionalInformationatMedicalPromotionalinformationwhichappearsonexhibitionstandsorisdistributedtoparticipantsatinternationalscientificcongressesandsymposiamayrefertopharmaceuticalproductswhicharenotregisteredinthecountrywherethemeetingtakesplace,orwhichareregisteredunderdifferentconditions,providedthatthefollowingconditionsareobserved:•Hostcountryregulationsshouldpermitsuchanarrangement;•Themeetingshouldbeatrulyinternational,scientificmeetingwithasignificantproportionofthespeakersandattendeesfromcountriesotherthanthecountrywherethemeetingtakesplace;RDPACCodeofPracticeI23•尚未在会议所在国注册的药品推广材料（不包括本准则第7.6.2中•如药品推广材料中包含在会议所适当且以有助于实现其科学、教育及会议本身的目的为宗旨。会员公司应避免选择名胜或铺张奢侈的地点举办医学互动交流项目。在选择医学互动交流项目的适当地点时还应遵守本准则第7条及IFPMA赞助•Promotionalmaterial(excludingpromotionalaidsasdescribedinArticle7.6.2)forapharmaceuticalproductnotregisteredinthecountryofthemeetingshouldbeaccompaniedbyasuitablestatementindicatingthecountriesinwhichtheproductisregisteredandmakeclearthatsuchproductisnotavailablelocally;•Promotionalmaterialwhichreferstotheprescribinginformation(indications,warnings,etc.)authorizedinacountryorcountriesotherthanthatinwhichthemeetingtakesplacebutwheretheproductisalsoregistered,shouldbeaccompaniedbyanexplanatorystatementindicatingthatregistrationconditionsdifferinternationally.Allmedicalinteractionprogramsmustbeheldinanappropriatevenuethatisconducivetothescientificoreducationalobjectivesandthepurposeofthemedicalinteractionprogram.Membercompaniesmustavoidusingrenownedorextravagantvenues.TheadditionalrequirementssetforthinArticle7ofthisCode,aswellastheIFPMAGuidanceonSponsorshipalsoapplyaccordingly.24IRDPAC行业行为准则注释13：13.会员公司应谨慎选择会议的举办地，以尽量减少参会者的旅行，并避免造成铺张奢侈的公众形象，避免选择与奢侈的娱乐活滑雪、高尔夫、赌博、邮轮等。IFPMA赞助指南所提供的其他原则和要求详见本准则附件一，或参考在IFPMA官网发布/更新的该指南文件(/resources/p